Job Description

Location : Senai, JohorBasic Salary : Up to RM 4,500Phone Allowance : RM50Travelling Allowance : RM 100In-process Quality Control:

• Demonstrate knowledge, compliance, and adherence to high standards of qua lity engineering, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), US FDA Quality System Regulations (21 Code of Federal Regulations 820), European Union Medical Device Directives & Regulations, and Malaysian Medical Device Authority (MDA) requirements.
• Perform, verify and authorize in-process quality control checks, packaging inspections, and shipment verification activities.
• Review and approval of documents and data generated from in-process quality control checks, packaging inspections and shipment verification activities.
• Review and approval of batch records i.e., Device History Records (DHR) from various stages of manufacturing.
• Issuance and preparation of Semi-finished & Finished Goods Final Release Documentation for the approval to Head of QA.
• Archival and maintenance of each production order batch documentations and records as part of the DHR for semi -finished & finaI release of finished goods.
• Monitoring and maintenance of list and physical inventory of archived (retention) samples, reject samples, quarantine samples as part of the product requirement.
• Escalate nonconformances / issues observed -during in-process check activities to management team and able to recommend improvement actions.

Manufacturing Support

• Preparation & issuance of chemicals for manufacturing use i.e., routine manufacturing and clean room cleaning activities.
• Performs in-process quality checks and in-process testing i.e., Friction test, silver analysis, Accuracy test for TSC products, etc.
• Performs Bioburden Assessment including sampling, sample preparation and data monitoring.
• Assist in Noble Metal recovery process.
• Participate in validation activities i.e., sampling & testing.
• Participate in investigations related to manufacturing (as applicable).

Laboratory Operations

• Demonstrate high level of Good Laboratory Practices (GLP).
• Performs analysis for finished products using Atomic Absorption Spectroscopy for determination of silver pickup.
• Performs analysis on stability (shelf life) studies samples as per the specified intervals.
• Ensure proper management of chemical storage and my inventory.
• Ensure proper management of Chemical Safety Data Sheet (SDS).
• Ensure proper maintenance of Laboratory glassware, instruments, equipment etc.
• Performs calibration of laboratory instruments & equipment according to calibration master list.
• Performs periodic review of Iaboratory instruments & equipment according to calibration masterlist.
• Planning of external calibratian for laboratory instrument & equipment according to calibration master list.
• Participate in laboratory related investigations and implementation of CAPA

Accountabilities and Authorities:

• Demonstrate high IeveI compliance to a II QMS procedures, quality objectives, quality policies and regulatory requirement
• To stop operations within own area of responsibility, when issues are identified that cause unacceptable risks for personnel safety and occupational health.
• To release in-process quality control results to the subsequent process if results meet specifications.
• To release test equipment upon in house calibration as per the calibration master list.
• Reject any production batches which does not meet the quality requirement upon testing.
• Provide in-process quality & Laboratory inputs to Site Quality lead.

Requirement

• Posesses Bachelor Degree in Chemical or related field
• Open for fresh graduate with relevant experience during internship

Reference Number:Contact Details:Siti_Roslan@persolkelly.comProfession:Others
OthersCompany:PERSOLKELLY MalaysiaDate Posted:19/03/2024 2:42:00 PM

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